Biomarkers for Therapy Response in Drug-resistant Tuberculosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02597621

Enrollment

192

Registered

2015-11-05

Start date

2013-03-31

Completion date

2021-01-31

Last updated

2024-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis, Multidrug-resistant

Brief summary

Multi-center, observational, prospective cohort study including patients with multidrug-resistant tuberculosis at different sites in Germany. The aim the study is the identification of biomarkers for therapy response.

Detailed description

The increasing rates of multidrug-resistant (MDR) tuberculosis (TB) are causing great concern. The current study that will be conducted at different centers in Germany. Biomarkers for treatment response during the course of the tuberculosis therapy will be evaluated. The study will be conducted with funding of the German Center for Infection Research (DZIF).

Interventions

OTHERno intervention

no intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects with confirmed pulmonary MDR-TB * Subject able and willing to give informed consent

Exclusion criteria

* HIV infection * physical or mental inability preventing study participation at the discretion of the investigator * member of a vulnerable or special population (prisoner, soldier, mentally ill, under guardianship) * age \<18 years.

Design outcomes

Primary

Measure	Time frame
Identification of biomarkers for therapy response	3 years

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026